FDA 510(k)

SHIFA STERILE DISPOSABLE SYRINGES

K-Number: K962614 · 1996-09-06

ApplicantInternational Regulatory Consultants

Decision Date1996-09-06

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SHIFA STERILE DISPOSABLE SYRINGES is the device name listed in this FDA 510(k) record. The listed applicant is International Regulatory Consultants. It received FDA 510(k) clearance on 1996-09-06 under 510(k) number K962614. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIFA STERILE DISPOSABLE SYRINGES?

SHIFA STERILE DISPOSABLE SYRINGES is a medical device that received FDA 510(k) clearance on 1996-09-06. The listed applicant is International Regulatory Consultants. The 510(k) number is K962614.

When did SHIFA STERILE DISPOSABLE SYRINGES receive FDA 510(k) clearance?

SHIFA STERILE DISPOSABLE SYRINGES received FDA 510(k) clearance on 1996-09-06, under 510(k) number K962614.

Who is the listed applicant for SHIFA STERILE DISPOSABLE SYRINGES?

The FDA 510(k) record lists International Regulatory Consultants as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHIFA STERILE DISPOSABLE SYRINGES?

The FDA product code for SHIFA STERILE DISPOSABLE SYRINGES is FMF.

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Other records listing International Regulatory Consultants as applicant

K981591VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT K971347MEDISURF K950012DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES K935280MEMOTHERM 10 BABY THERMOMETER

Related Devices (Code: FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.